Health informatics. Identification of medicinal products. Data elements and structures for the Unique Identification and Exchange of regulated Pharmaceutical Product Information (ISO 11616:2017)
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ISO 11616:2017 is intended to provide specific levels of information relevant to the identification of a Medicinal Product or group of Medicinal Products. It defines the data elements, structures and relationships between data elements that are required for the exchange of regulated information, in order to uniquely identify pharmaceutical products. This identification is to be applied throughout the product lifecycle to support pharmacovigilance, regulatory and other activities worldwide. In addition, ISO 11616:2017 is essential to ensure that pharmaceutical product information is assembled in a structured format with transmission between a diverse set of stakeholders for both regulatory and clinical (e.g. e-prescribing, clinical decision support) purposes. This ensures interoperability and compatibility for both the sender and the recipient. ISO 11616:2017 is not intended to be a scientific classification for pharmaceutical products. Rather, it is a formal association of particular data elements categorised in prescribed combinations and uniquely identified when levelling degrees of information are incomplete. This allows for Medicinal Products to be unequivocally identified on a global level. References to other normative IDMP and messaging standards for pharmaceutical product information are included in Clause 2, to be applied in the context of ISO 11616:2017. Medicinal products for veterinary use are out of scope of ISO 11616:2017.
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Sisällysluettelo
Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and abbreviated terms
4 Conformance terminology and context as it relates to the ISO IDMP standards and corresponding IDMP technical specifications
5 Requirements
5.1 Elements required for the unique identification of pharmaceutical products
5.2 Exchange of pharmaceutical product information
6 Description of the information modelling principles and practices
6.1 General considerations
6.2 Conceptual overview diagrams
6.3 High-level diagrams
6.4 Detailed description diagrams
7 Identifying characteristics for the identification of pharmaceutical products
7.1 Pharmaceutical product identification strata and levels
7.2 Cardinality
7.3 Representation of strength concentration
7.4 Pharmaceutical product identifier (PhPID)
7.5 Pharmaceutical product substance stratum elements (PhPID_SUB_Lx)
7.6 Pharmaceutical product specified substance stratum elements (PhPID_SpSUB_Lx)
7.7 Identifying characteristics to express strength
8 Relationship between MPID/PCID and PhPID
8.1 Concepts required for the unique identification of a Medicinal Product and the association with PhPIDs
ISO 11238:2012 Health informatics -- Identification of medicinal products -- Data elements and structures for the unique identification and exchange of regulated information on substances
ISO 11239:2012 Health informatics -- Identification of medicinal products -- Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging
ISO 11240:2012 Health informatics -- Identification of medicinal products -- Data elements and structures for the unique identification and exchange of units of measurement
ISO 11238:2012 Health informatics -- Identification of medicinal products -- Data elements and structures for the unique identification and exchange of regulated information on substances
ISO 11239:2012 Health informatics -- Identification of medicinal products -- Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging
ISO 11240:2012 Health informatics -- Identification of medicinal products -- Data elements and structures for the unique identification and exchange of units of measurement
ISO 11615:2017 Health informatics -- Identification of medicinal products -- Data elements and structures for the unique identification and exchange of regulated medicinal product information
ISO 3166-1:2013 Codes for the representation of names of countries and their subdivisions -- Part 1: Country codes
ISO/TS 19844:2016 Health informatics -- Identification of medicinal products -- Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances
ISO/TS 20440:2016 Health informatics -- Identification of medicinal products -- Implementation guide for ISO 11239 data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging
ISO/TS 20443:2017 Health informatics -- Identification of medicinal products -- Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information
ISO/TS 20451:2017 Health informatics -- Identification of medicinal products -- Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information